Job Description
**Regulatory Affairs Coordinator (Open Rank: Senior-Principal)**
**Description**
**University of Colorado Anschutz Medical Campus**
**Department: Ophthalmology**
**Job Title: Regulatory Affairs Coordinator (Open Rank: Senior-Principal)**
**Position #00846414 - Requisition #39535**
**Job Summary:**
Key Responsibilities:
+ Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
+ Coordinate regulatory documentation for multi-site and industry-sponsored clinical trials.
+ Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
+ Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
+ Track and maintain investigator qualifications, including CVs, medical lice...
**Description**
**University of Colorado Anschutz Medical Campus**
**Department: Ophthalmology**
**Job Title: Regulatory Affairs Coordinator (Open Rank: Senior-Principal)**
**Position #00846414 - Requisition #39535**
**Job Summary:**
Key Responsibilities:
+ Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
+ Coordinate regulatory documentation for multi-site and industry-sponsored clinical trials.
+ Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
+ Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
+ Track and maintain investigator qualifications, including CVs, medical lice...